FDA.reportPublic FDA data

SCR REMOVAL TREPHINE 5.5MM ID

Primary DI
00880304385702
Brand
SCR REMOVAL TREPHINE 5.5MM ID
Company
Biomet Orthopedics, LLC
Model
473684
Catalog number
473684
Published
2020-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWKTREPHINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWKTrephineOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304385702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304385702008803043857028803043857020880304385702

GMDN Terms#

Term, Definition table
TermDefinition
Screw extractor, reusableA hand-held manual surgical tool designed to remove implanted screws that have a damaged screw recess by self-tapping into the defective recess/head and providing sufficient grip to rotate and remove the screw in the normal way. It typically has a conical tip. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888480584162PRO OSTEON 2002B0402B0402015-10-24
00888480584179PRO OSTEON 2002B0452B0452015-10-24
00888480584186PRO OSTEON 2002B0752B0752015-10-24
00888480584247PRO OSTEON 2002G022G022015-10-24
00888480584254PRO OSTEON 2002G052G052015-10-24
00888480584339PRO OSTEON 200R2RG0052RG0052015-10-24
00888480584346PRO OSTEON 200R2RG022RG022015-10-24
00888480584353PRO OSTEON 200R2RG052RG052015-10-24
00888480584360PRO OSTEON 200R2RG152RG152015-10-24
00888480584476PRO OSTEON 5005B0405B0402015-10-24
00888480584483PRO OSTEON 5005B0755B0752015-10-24
00888480584490PRO OSTEON 5005B1005B1002015-10-24
00888480584575PRO OSTEON 5005G055G052015-10-24
00888480584582PRO OSTEON 5005G105G102015-10-24
00888480584599PRO OSTEON 5005G155G152015-10-24
00888480584629PRO OSTEON 5005G305G302015-10-24
00888480584681PRO OSTEON 500R5RB0105RB0102015-10-24
00888480584698PRO OSTEON 500R5RB0145RB0142015-10-24
00888480584704PRO OSTEON 500R5RB0245RB0242015-10-24
00888480584711PRO OSTEON 500R5RB0405RB0402015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088713572PRINCETONPrinceton Medical Group, Inc.HWK2026-08-25
00850088713497PRINCETONPrinceton Medical Group, Inc.HWK2026-08-14
00850088713503PRINCETONPrinceton Medical Group, Inc.HWK2026-08-14
00810146164715RedifixTRAX SURGICAL INC.HWK2026-07-20
108101284636284.5mm Can. Full Thickness DrillT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWK2026-05-13
108101284636357.0mm Can. Full Thickness DrillT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWK2026-05-13
108101284636428.0mm Can. Full Thickness DrillT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWK2026-05-13
108101284636599.0mm Can. Full Thickness DrillT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWK2026-05-13
00190376706467InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706474InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706481InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706498InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706504InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706511InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706528InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706535InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706542InvictusALPHATEC SPINE, INC.HWK2026-04-09
03662663217477Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663217484Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663217491Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663217507Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663134392C-THRU Anterior Spinal Spacer SystemHighridge Medical, LLCHWK2025-12-03
03662663136327Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136334Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136341Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136358Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136365Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
06957277203112iTool®Apex (Guangzhou) Tools & Orthopedics Co.HWK2025-10-31
06957277203129iTool®Apex (Guangzhou) Tools & Orthopedics Co.HWK2025-10-31
06957277203136iTool®Apex (Guangzhou) Tools & Orthopedics Co.HWK2025-10-31